(230 days)
The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpiece. The system is to be used with existing Unity Alpha single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
The Unity Ultrasonic System is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-laotic acid (PLLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, teadon, and bone at a repair site. An olectrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, rendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management. Modifications are being made to the electrical generator and ultrasonic handpiece components of the ultrasonic system to improve overall system performance and to enhance user interface features. Additionally, the handpiece is being modified to include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone.
The provided text describes a 510(k) summary for the Bonutti Research, Inc. Unity Ultrasonic System. It details changes made to the system and compares it to predicate devices. However, the document does not provide specific acceptance criteria or the details of a study that proves the device meets such criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds beyond general "mechanical strength testing").
Therefore, I cannot populate the requested table or answer most of the questions fully as the information is not present in the provided text.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (beyond "electrical output compared" and "mechanical strength testing conducted") |
Explanation: The document states that "Design verification testing identified and conducted as part of the predicate comparison... compared the electrical output of the modified Unity Ultrasonic System electrical generator and ultrasonic handpiece to similar component predicate devices. Mechanical strength testing was also conducted with Unity Alpha predicate devices: for both the modified Unity Ultrasonic System and its predicate ultrasonic systems." However, it does not provide the specific numerical acceptance criteria (e.g., "electrical output must be within X% of predicate") nor the actual measured performance values.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing is described as "Design verification testing" and "mechanical strength testing," implying laboratory or bench testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes design verification and mechanical strength testing, not studies requiring expert-established ground truth for performance metrics like those for diagnostic AI systems.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable for the same reason as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is a "Fixation Device" (Unity Ultrasonic System) for surgical use, not a diagnostic imaging or AI-assisted interpretation tool. The testing described is related to the device's mechanical and electrical properties.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable as the device is a surgical fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "mechanical strength testing" and "electrical output comparison," the ground truth would inherently be engineering specifications, physical measurements, and the performance characteristics of the predicate devices. It is not an expert consensus, pathology, or outcomes data in the context of diagnostic performance.
8. The sample size for the training set:
- Not applicable. The document describes device modifications and comparative testing, not the development of a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through design verification and mechanical testing, specifically for an ultrasonic surgical fixation system. It does not contain the detailed performance metrics, study designs, or ground truth establishment methods typically associated with AI/ML-driven diagnostic devices or clinical comparative effectiveness studies.
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Image /page/0/Picture/0 description: The image shows the words "BONUTTI" and "TECHNOLOGIES" stacked on top of each other. The word "BONUTTI" is in a larger font than the word "TECHNOLOGIES". The letters are made up of small dots, giving the image a textured appearance. The image is in black and white.
0 50x 1357 lfingham, IL 62401 ודעס ספּאַזונגעסטע אַנאַמאַקענסאַ
SEP 1 0 2009
Bonutti Research, Inc. - Unity Ultrasonic System 1.090175 June 29, 2009
510(k) SUMMARY
The following information is submitted in accordance with the requirements of 21 CFR 807,92:
| Contact Person: | Patrick Balsmann, MBA, MS, RAC |
|---|---|
| Director, Regulatory/Clinical Affairs & QA | |
| Bonutti Research, Inc., | |
| P.O. Box 1367 | |
| Effingham, Illinois 62401 | |
| Phone: (217) 342-3412, ext. 321 | |
| Fax: (217) 342-1043 |
Date Prepared: June 29, 2009
Proprietary Name: Unity Ultrasonic System
Common Name: Fixation Device
Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.
Device Description: The Unity Ultrasonic System is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-laotic acid (PLLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, teadon, and bone at a repair site. An olectrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, rendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management. Modifications are being made to the electrical generator and ultrasonic handpiece components of the ultrasonic system to improve overall system performance and to enhance user interface features. Additionally, the handpiece is being modified to include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone.
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K090175$\frac{2}{2}$
Bonutti Research, Inc. - Unity Ultrasonic System 510(k) Summary - June 29, 2009 Page 2
Indications for Use: The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpiece. The system is to be used with existing Unity Alpha single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
Predicate Device(s): The Unity Ultrasonic System is similar in design and intended use I redicate Device(s). The Dury - electrical generators and ultrasonic handpieces used in sutureless fixation and previously determined substantially equivalent.
Predicate Comparison: Design verification testing identified and conducted as part of I i culture Comparison: compared the electrical output of the modified Unity Ultrasonic System electrical generator and ultrasonic handpiece to similar component predicate devices. Mechanical strength testing was also conducted with Unity Alpha predicate devices: for both the modified Unity Ultrasonic System and its predicate ultrasonic systems.
Submitted by:
Cathy Baker
Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 1 0 2009
Bonutti Research, Inc. % Mr. Patrick G. Balsmann 2600 South Raney Street P.O. Box 1367 Effingham, IL 62401
SEP. 1 2009
Re: K090175 Trade/Device Name: Unity Ultrasonic System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC. MAI
Dated: August 27, 2009
Received: August 28, 2009
Dear Mr. Balsmann:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Patrick G. Balsmann
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdriv/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchus
Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K090175
Device Name: Unity Alpha System
Indications For Use: The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpiece. The system is to be used with existing Unity Alpha single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
X Prescription Use ... AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Sumita for mxm
(Division Dir
(Vivision Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090175
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.